LTZ Therapeutics Inc.
Director/Associate Director, Clinical Operations Redwood City, USA
LTZ Therapeutics Inc., Baltimore, Maryland, United States
Director/Associate Director, Clinical Operations
Job Description
The Clinical Operations (Director/Associate Director) is a key member of the Clinical Operations team leading the successful execution of clinical trials. The Clinical Operations Director provides trial operational oversight of CROs and vendors and is responsible for all aspects of Phase I through pivotal clinical oncology trials. This role also assures adherence to GCP, regulations and applicable procedures, in addition to protocol compliance and that of study related plans. We are seeking a highly motivated Clinical Operations Director. The position is full-time, and based at our headquarters in Redwood City, CA. The ideal candidate is an individual who is interested in working in a fast-paced, dynamic, and highly collaborative biotech environment with a willingness and ability to successfully take on new challenges. The candidate will be part of a cross-functional project team working on early phase clinical trials. Essential Functions and Responsibilities
Responsible for growing and managing projects, and daily work activities for the Clinical Team. Independently manage all components of complex oncology clinical trials, leading a cross-functional management team. Ensure clinical trial activities and deliverables are completed on-time and within budget. Vendor oversight (e.g., CRO, PK/Central Lab, Drug Supply, IXRS, eTMF) for adherence to budget, timelines, and organizational objectives of individual protocols/programs. Develop strong vendor relationships and ensure continuity of relationships through all phases of the trial. Involved in the identification, evaluation, selection, and oversight of all clinical trial sites. Oversee and participate in the development of study documents and tools including study protocols, consent forms, and project plans. Obtain and maintain an in-depth understanding of the study protocol and related procedures to contribute strongly to study team knowledge by sharing best practices, making recommendations for continuous improvement, and providing training as appropriate/required. Partner efficiently and effectively with clinical trial sites to ensure smooth study conduct. Coordinate & manage various tasks in collaboration with other sponsor roles to achieve site readiness, such as study materials and approval for drug shipping/receipt according to procedure. Perform timely reviews of monitoring reports from CRO and associated deliverables demonstrating sponsor oversight. Oversee ongoing study data reviews and data cleaning activities. Responsible for inspection readiness at all times. Perform periodic reviews of the CRO eTMF/TMF to ensure adherence with standards and compliance with the relevant regulations and guidelines. Work with vendors to revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met. Support financial management of the study which includes review and approval of site and vendor invoices. Conduct/attend internal/external meetings for assigned clinical trials. May develop SOPs, best practices, and facilitate their implementation. Education, Experience, Knowledge, Skills and Abilities
BA/BS in related scientific or healthcare field; a combination of relevant education and applicable job experience may be considered. 8-10 years of clinical trial management experience. Experience in running a trial from start to finish; initiating the trial; ICF generation, site feasibility/start up training, contract and budget negotiation, vendor management, CRF design, maintaining a trial and study close out. Excellent communication skills, including the ability to understand and present technical information effectively. Strong understanding and working knowledge of clinical research, phases of clinical studies, current ICH GCP, FDA regulations, & country clinical research law & guidelines. Strong understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines. Strong leadership, effective decision making, and problem-solving skills required. Hands-on knowledge of Good Documentation Practices. Perform independently and professionally when managing both site/vendor oversight and monitoring responsibilities, and as applied across multiple protocols, sites, and therapeutic areas. Strong IT skills (Use of MS office, use of various clinical IT applications on computer, tablet, and mobile devices) and ability to adapt to new IT applications on various devices. Ability to understand and analyze data/metrics and act appropriately. Possess effective time management, organizational and interpersonal skills, conflict management, problem-solving skills. High sense of accountability/urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment. Work effectively in a matrix cross-functional environment. Ability to establish and maintain culturally sensitive working relationships. Previous oncology experience required and experience with solid tumors and immunotherapy/biologics preferred. Ability to travel up to 15%. EEO Statement
LTZ Therapeutics is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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Job Description
The Clinical Operations (Director/Associate Director) is a key member of the Clinical Operations team leading the successful execution of clinical trials. The Clinical Operations Director provides trial operational oversight of CROs and vendors and is responsible for all aspects of Phase I through pivotal clinical oncology trials. This role also assures adherence to GCP, regulations and applicable procedures, in addition to protocol compliance and that of study related plans. We are seeking a highly motivated Clinical Operations Director. The position is full-time, and based at our headquarters in Redwood City, CA. The ideal candidate is an individual who is interested in working in a fast-paced, dynamic, and highly collaborative biotech environment with a willingness and ability to successfully take on new challenges. The candidate will be part of a cross-functional project team working on early phase clinical trials. Essential Functions and Responsibilities
Responsible for growing and managing projects, and daily work activities for the Clinical Team. Independently manage all components of complex oncology clinical trials, leading a cross-functional management team. Ensure clinical trial activities and deliverables are completed on-time and within budget. Vendor oversight (e.g., CRO, PK/Central Lab, Drug Supply, IXRS, eTMF) for adherence to budget, timelines, and organizational objectives of individual protocols/programs. Develop strong vendor relationships and ensure continuity of relationships through all phases of the trial. Involved in the identification, evaluation, selection, and oversight of all clinical trial sites. Oversee and participate in the development of study documents and tools including study protocols, consent forms, and project plans. Obtain and maintain an in-depth understanding of the study protocol and related procedures to contribute strongly to study team knowledge by sharing best practices, making recommendations for continuous improvement, and providing training as appropriate/required. Partner efficiently and effectively with clinical trial sites to ensure smooth study conduct. Coordinate & manage various tasks in collaboration with other sponsor roles to achieve site readiness, such as study materials and approval for drug shipping/receipt according to procedure. Perform timely reviews of monitoring reports from CRO and associated deliverables demonstrating sponsor oversight. Oversee ongoing study data reviews and data cleaning activities. Responsible for inspection readiness at all times. Perform periodic reviews of the CRO eTMF/TMF to ensure adherence with standards and compliance with the relevant regulations and guidelines. Work with vendors to revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met. Support financial management of the study which includes review and approval of site and vendor invoices. Conduct/attend internal/external meetings for assigned clinical trials. May develop SOPs, best practices, and facilitate their implementation. Education, Experience, Knowledge, Skills and Abilities
BA/BS in related scientific or healthcare field; a combination of relevant education and applicable job experience may be considered. 8-10 years of clinical trial management experience. Experience in running a trial from start to finish; initiating the trial; ICF generation, site feasibility/start up training, contract and budget negotiation, vendor management, CRF design, maintaining a trial and study close out. Excellent communication skills, including the ability to understand and present technical information effectively. Strong understanding and working knowledge of clinical research, phases of clinical studies, current ICH GCP, FDA regulations, & country clinical research law & guidelines. Strong understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines. Strong leadership, effective decision making, and problem-solving skills required. Hands-on knowledge of Good Documentation Practices. Perform independently and professionally when managing both site/vendor oversight and monitoring responsibilities, and as applied across multiple protocols, sites, and therapeutic areas. Strong IT skills (Use of MS office, use of various clinical IT applications on computer, tablet, and mobile devices) and ability to adapt to new IT applications on various devices. Ability to understand and analyze data/metrics and act appropriately. Possess effective time management, organizational and interpersonal skills, conflict management, problem-solving skills. High sense of accountability/urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment. Work effectively in a matrix cross-functional environment. Ability to establish and maintain culturally sensitive working relationships. Previous oncology experience required and experience with solid tumors and immunotherapy/biologics preferred. Ability to travel up to 15%. EEO Statement
LTZ Therapeutics is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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